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Approval Alert: FDA Approves AbbVie’s Epkinly® for Follicular Lymphoma

Jun 26, 2024

On 26 June 2024, AbbVie announced that its Epkinly® (epcoritamab) received FDA approval for the treatment of adults with relapsed or refractory follicular lymphoma.  This approval makes Epkinly® the first and only subcutaneous bispecific antibody approved in the US to treat this patient population.

Epkinly® is being co-developed with Genmab, using its proprietary DuoBody® technology, which is designed to selectively direct cytotoxic T cells to elicit an immune response toward target cell types.  This news follows the FDA granting priority review of AbbVie’s supplemental Biologics License Application for Epkinly® in February this year.